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FDA Date: 12/6/11
Nplate (romiplostim)
Goals of the NPLATE REMS Program
To inform healthcare providers about the risks of progression of myelodysplastic syndromes (MDS) to acute myelogenous leukemia (AML), thrombotic/thromboembolic complications, bone marrow reticulin formation, bone marrow fibrosis, worsened thrombocytopenia after cessation of Nplate, and Nplate medication errors associated with serious outcomes.
REMS Elements• Communication Plan